DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Survanta (Beractant) - Summary

 
 



SURVANTA SUMMARY

SURVANTA® (beractant) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. SURVANTA contains no preservatives.

SURVANTA is indicated for prevention and treatment ("rescue") of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications.

In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible, preferably within 15 minutes of birth.

To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours of age.


See all Survanta indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Survanta (Beractant)

ARDS (Acute Respiratory Distress Syndrome)
Source: MedicineNet Deep Vein Thrombosis Specialty [2017.07.31]
Title: ARDS (Acute Respiratory Distress Syndrome)
Category: Diseases and Conditions
Created: 3/12/2007 12:00:00 AM
Last Editorial Review: 7/31/2017 12:00:00 AM

more news >>

Published Studies Related to Survanta (Beractant)

A Randomized, Controlled Trial of Poractant Alfa versus Beractant in the Treatment of Preterm Infants with Respiratory Distress Syndrome. [2011.11.21]
We prospectively evaluated the differences in clinical responses and short-term outcomes in preterm infants with respiratory distress syndrome (RDS) treated with poractant alfa or beractant. Premature infants with RDS were randomized to poractant alfa or beractant treatment between July 2008 and June 2009...

Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. [2010.10]
OBJECTIVE: Comparison of the differences between availability of animal-derived surfactant preparations used to treat premature infants is incomplete. The objective of this study was to assess the short-term treatment efficacy of the two most commonly used surfactant preparations in the United States, beractant (100 mg kg(-1) initial and subsequent doses) and poractant alfa (200 mg kg(-1) initial and 100 mg kg(-1) subsequent doses), in very premature, mechanically ventilated infants <30 weeks gestation with respiratory distress syndrome (RDS)... CONCLUSION: This study suggests significant short-term benefits to the use of the larger initial dose of poractant alfa than beractant in very premature infants with RDS. Further studies involving a larger number of preterm infants are needed to assess long-term effects.

Comparison of Infasurf (calfactant) and Survanta (beractant) in the prevention and treatment of respiratory distress syndrome. [2005.08]
BACKGROUND: In biophysical and animal testing, Infasurf develops lower surface tension and restores total surfactant activity better than Survanta... CONCLUSION: Early trial closure prevents us from either accepting or rejecting our null hypothesis.

A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome. [2005.06]
AIM: To compare the effects of beractant and poractant in neonatal respiratory distress syndrome (RDS)... CONCLUSIONS: Infants with RDS treated with poractant had a lower FiO2 requirement during the first 48 h compared to infants who received beractant. Infants who received poractant also had fewer PDAs than infants who received beractant. The difference in FiO2 was not associated with a difference in age of first extubation, total intubation time, or incidence of bronchopulmonary dysplasia between groups.

A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants. [2005.04]
BACKGROUND AND OBJECTIVE: Evidence suggests that synthetic surfactants consisting solely of phospholipids can be improved through the addition of peptides, such as sinapultide, that mimic the action of human surfactant protein-B (SP-B). A synthetic surfactant containing a mimic of SP-B may also reduce the potential risks associated with the use of animal-derived products. Our objective was to compare the efficacy and safety of a novel synthetic surfactant containing a functional SP-B mimic (lucinactant; Discovery Laboratories, Doylestown, PA) with those of a non-protein-containing synthetic surfactant (colfosceril palmitate; GlaxoSmithKline, Brentford, United Kingdom) and a bovine-derived surfactant (beractant; Abbott Laboratories, Abbott Park, IL) in the prevention of neonatal respiratory distress syndrome (RDS) and RDS-related death... CONCLUSIONS: Lucinactant is a more effective surfactant preparation than colfosceril palmitate for the prevention of RDS. In addition, lucinactant reduces the incidence of BPD, compared with colfosceril palmitate, and decreases RDS-related mortality rates, compared with beractant. Therefore, we conclude that lucinactant, the first of a new class of surfactants containing a functional protein analog of SP-B, is an effective therapeutic option for preterm infants at risk for RDS.

more studies >>

Clinical Trials Related to Survanta (Beractant)

Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants [Terminated]
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome [Completed]
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.

Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome [Withdrawn]
This is a null hypothesis study. The investigators hypothesize that there will be no difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute intervals after administration of either surfactant and there will be no differences in the number of doses needed between the two surfactants in premature infants admitted to our NICU.

Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage [Completed]
The incidence of pulmonary hemorrhage (PH) was about 1. 3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH. In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.

Perfusion Index Variability in Respiratory Distress Syndrome [Completed]

more trials >>

Reports of Suspected Survanta (Beractant) Side Effects

Pulmonary Haemorrhage (5)Death (3)Drug Ineffective (1)Pneumomediastinum (1)Overdose (1)Medication Error (1)Hypoxia (1)Oxygen Saturation Decreased (1)Neonatal Respiratory Distress Syndrome (1)


Page last updated: 2017-07-31

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017